EN ISO 18369-3:2017

Ophthalmic optics - Contact lenses - Part 3: Measurement methods (ISO 18369-3:2017, Corrected version 2017-10-01)

ISO 18369-3:2017 specifies the methods for measuring the physical and optical properties of contact lenses specified in ISO 18369‑2, i.e. radius of curvature, label back vertex power, diameter, thickness, inspection of edges, inclusions and surface imperfections and determination of spectral transmittance. This document also specifies the equilibrating solution and standard saline solution for testing of contact lenses.

Augenoptik - Kontaktlinsen - Teil 3: Messverfahren (ISO 18369-3:2017, korrigierte Fassung 2017-10-01)

Optique ophtalmique - Lentilles de contact - Partie 3: Méthodes de mesure (ISO 18369-3:2017, Version corrigée 2017-10-01)

ISO 18369-3:2017 spécifie les méthodes de mesure des propriétés optiques et physiques des lentilles de contact, telles que décrites dans l'ISO 18369‑2, il s'agit en l'occurrence du rayon de courbure, de la puissance frontale arrière déclarée, du diamètre, de l'épaisseur, du contrôle des bords, des inclusions, et des imperfections de surface et de la détermination du facteur spectral de transmission. Le présent document spécifie également la solution utilisée pour l'équilibrage et la solution saline étalon pour l'essai des lentilles de contact.

Očesna optika - Kontaktne leče - 3. del: Merilne metode (ISO 18369-3:2017)

Ta dokument določa merilne metode za merjenje fizičnih in optičnih lastnosti kontaktnih leč, navedenih v standardu ISO 18369-2, tj. polmer ukrivljenosti, nazivna moč leče glede na vrh na zadnji strani, premer, debelina, pregled robov, vključki in nepravilnosti na površini ter določanje spektralne prepustnosti.
Ta dokument določa tudi raztopino za uravnoteženje in standardno fiziološko raztopino za preskušanje kontaktnih leč.

General Information

• Status: Published
• Publication Date: 19-Sep-2017
• Withdrawal Date: 30-Mar-2018
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 20-Sep-2017
• Completion Date: 20-Sep-2017
• Ref Project: SIST EN ISO 18369-3:2017 - Ophthalmic optics - Contact lenses - Part 3: Measurement methods (ISO 18369-3:2017)

Relations

• Replaces: EN ISO 18369-3:2006 - Ophthalmic optics - Contact lenses - Part 3: Measurement methods (ISO 18369-3:2006)
• Effective Date: 27-Sep-2017

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2017
1DGRPHãþD
SIST EN ISO 18369-3:2006
2þHVQDRSWLND.RQWDNWQHOHþHGHO0HULOQHPHWRGH,62
Ophthalmic optics - Contact lenses - Part 3: Measurement methods (ISO 18369-3:2017)
Augenoptik - Kontaktlinsen - Teil 3: Messverfahren (ISO 18369-3:2017)
Optique ophtalmique - Lentilles de contact - Partie 3: Méthodes de mesure (ISO 18369-
3:2017)
Ta slovenski standard je istoveten z: EN ISO 18369-3:2017
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 18369-3
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2017
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 18369-3:2006
English Version
Ophthalmic optics - Contact lenses - Part 3: Measurement
methods (ISO 18369-3:2017)
Optique ophtalmique - Lentilles de contact - Partie 3: Augenoptik - Kontaktlinsen - Teil 3: Messverfahren
Méthodes de mesure (ISO 18369-3:2017) (ISO 18369-3:2017)
This European Standard was approved by CEN on 1 July 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18369-3:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 18369-3:2017) has been prepared by Technical Committee ISO/TC 172 “Optics
and photonics” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the
secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2018, and conflicting national standards shall
be withdrawn at the latest by March 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 18369-3:2006.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 18369-3:2017 has been approved by CEN as EN ISO 18369-3:2017 without any
modification.
INTERNATIONAL ISO
STANDARD 18369-3
Second edition
2017-08
Ophthalmic optics — Contact lenses —
Part 3:
Measurement methods
Optique ophtalmique — Lentilles de contact —
Partie 3: Méthodes de mesure
Reference number
ISO 18369-3:2017(E)
©
ISO 2017
ISO 18369-3:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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ii © ISO 2017 – All rights reserved

ISO 18369-3:2017(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Methods of measurement for contact lenses . 1
4.1 General . 1
4.2 Radius of curvature . 2
4.2.1 General. 2
4.2.2 Optical spherometry (rigid contact lenses) . 3
4.2.3 Sagittal height method . 6
4.3 Label back vertex power .11
4.3.1 General.11
4.3.2 Focimeter specification .11
4.3.3 Calibration .12
4.3.4 Focimeter measurement of rigid lenses .13
4.3.5 Focimeter measurement of hydrogel lenses .13
4.3.6 Measurement of hydrogel contact lenses by immersion in saline .13
4.3.7 Addition power measurement .14
4.4 Diameters and widths .14
4.4.1 Total diameter .14
4.4.2 Zone diameters and widths .19
4.5 Thickness .20
4.5.1 General.20
4.5.2 Dial gauge method .20
4.5.3 Low-force mechanical gauge method .21
4.6 Edge inspection .22
4.7 Determination of inclusions and surface imperfections .22
4.8 Spectral transmittance .23
4.8.1 General.23
4.8.2 Instrument specification, test conditions and procedure .23
4.9 Saline solution for testing .24
4.9.1 General.24
4.9.2 Formulation .24
4.9.3 Preparation procedure .25
4.9.4 Packaging and labelling .25
5 Test report .26
Annex A (informative) Measurement of rigid contact lens curvature using interferometry .27
Annex B (informative) Measurement of label back vertex power of soft contact lenses
immersed in saline using the Moiré deflectometer or Hartmann methods .29
Annex C (informative) Measurement of the radius of curvature of contact lenses using
the ophthalmometer .33
Annex D (informative) Paddle support for focimeters used for power measurements of
contact lenses .38
Bibliography .40
ISO 18369-3:2017(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the
...